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 Table of Contents  
PROTOCOL
Year : 2022  |  Volume : 6  |  Issue : 2  |  Page : 87-92

Efficacy of Ksharasutra prepared through automated machine and manual process in fistula-in-ano: A study protocol for a double-blind, randomized controlled trial


1 Department of Ayurveda, Central Council for Research in Ayurvedic Sciences, Ministry of Ayush, Govt. of India, New Delhi, India
2 Department of Ayurveda, Central Ayurveda Research Institute, New Delhi, India
3 Biostatistical Unit, Central Council for Research in Ayurvedic Sciences, Ministry of Ayush, Govt. of India, New Delhi, India
4 Central Council for Research in Ayurvedic Sciences, Ministry of Ayush, Govt. of India, New Delhi, India

Date of Submission01-Jul-2022
Date of Acceptance29-Aug-2022
Date of Web Publication12-Oct-2022

Correspondence Address:
Dr. Amit K Rai
Central Council for Research in Ayurvedic Sciences, Ministry of Ayush, Govt. of India, 61-65, Institutional Area, Opposite D-Block, Janakpuri, New Delhi 110058
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/jras.jras_95_22

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  Abstract 

BACKGROUND: The manufacturing process of Ksharasutra is still predominantly manual, even in the current era. It inherently leads to small-scale production and restricted availability of this effective treatment. CCRAS has developed a prototype of an automated machine to manufacture the Ksharasutra on a large scale. OBJECTIVE: This clinical study will investigate the safety and efficacy of the Ksharasutra prepared through the automated machine and compare its efficacy with the manually prepared Ksharasutra. MATERIALS AND METHODS: This study is a double-blind, randomized controlled, parallel-group trial being conducted at the Central Ayurveda Research Institute, New Delhi. A total of 100 participants will be enrolled in the study. Individuals of any sex aged 18–60 years and diagnosed with fistula-in-ano complaining of perianal discharge, pain, tenderness, itching, and induration will be enrolled in the trial. The enrolled participants will be managed by the automated machine-prepared Ksharasutra in the trial group and the manually prepared Ksharasutra in the control group. The Ksharasutra will be changed every week till the fistula tract is completely cut off. The outcome measures include the change in the quality of life (assessed through the SF-36 questionnaire), unit cutting time of the fistula tract, the proportion of participants having complete healing of the fistula tract, and the incidence of adverse events. DISCUSSION: The conventional surgical treatment of fistula-in-ano is associated with a significant recurrence rate and a high risk of impaired anal continence. Compared with conventional treatment, Ksharasutra therapy is simple, cost-effective, and associated with minor post-operative care, minimal complications, and a low recurrence rate. However, small-scale manufacturing due to manual preparation, non-uniformity of techniques involved in the manufacturing of Ksharasutra, and so on limits the availability and quality of this therapy. Awareness regarding the benefits of Ksharasutra therapy and availability of surgeons experienced in this procedure can play a significant role in improving the accessibility of this para-surgical technique. TRIAL REGISTRATION: CTRI/2021/12/038414, dated 3 Dec. 2021

Keywords: 
Bhagandara, chemical seton, fistula-in-ano, Ksharasutra, para-surgical procedure


How to cite this article:
Rai AK, Yadav B, Panigrahi HK, Singhal R, Chandrasekhararao B, Rana RK, Srikanth N. Efficacy of Ksharasutra prepared through automated machine and manual process in fistula-in-ano: A study protocol for a double-blind, randomized controlled trial. J Res Ayurvedic Sci 2022;6:87-92

How to cite this URL:
Rai AK, Yadav B, Panigrahi HK, Singhal R, Chandrasekhararao B, Rana RK, Srikanth N. Efficacy of Ksharasutra prepared through automated machine and manual process in fistula-in-ano: A study protocol for a double-blind, randomized controlled trial. J Res Ayurvedic Sci [serial online] 2022 [cited 2023 Feb 5];6:87-92. Available from: http://www.jrasccras.com/text.asp?2022/6/2/87/358306




  Introduction Top


Fistula-in-ano is one of the most prevalent anorectal diseases. It presents a chronic granulating tract that runs from the anal canal to the perianal skin or perineum. The patients of fistula-in-ano have substantial discomfort and morbidity as a result of it. The clinical features of fistula-in-ano resemble the disease condition described in Ayurveda as Bhagandara. Bhagandara is considered a difficult-to-cure disease in Ayurveda.[1] The conventional management of fistula-in-ano includes fistulotomy, fistulectomy, seton placing, chemical destruction of the fistula tract by corrosives, ligation of the inter-sphincteric fistula tract, fibrin glues, advancement flaps, and expanded adipose-derived stem cells.[2] Ayurveda has suggested various oral interventions, local applications, surgical procedures, and para-surgical measures for the management of Bhagandara.

Extensive surgery within and surrounding the anal canal, prolonged hospitalization, high recurrence rate, and anal incontinence are the most common problems associated with open surgery (fistulotomy or fistulectomy) of the fistula-in-ano. The other option, i.e., chemical seton, namely, “Ksharasutra” (Ayurveda medicine coated cotton thread used for chemical cauterisation), prescribed for the management of Bhagandara in Ayurveda, is found to be more effective in routine clinical practice. Management of fistula-in-ano with Ksharasutra is easy and cost-effective, with comparatively lesser pain and hospitalization duration, minimal complications, and a low recurrence rate. Further, the patient remains ambulatory during the complete course of treatment due to lesser post-operative complications. The Indian Council of Medical Research (ICMR) has validated the efficacy of this treatment modality through clinical trials and highlighted the superiority of Ksharasutra over conventional surgery in managing fistula-in-ano.[3] It is the preferred choice for managing fistula-in-ano, especially recurrent and complex fistula. The standards for manufacturing Ksharasutra are available in the Ayurvedic Pharmacopeia of India.

The preparation of Ksharasutra involved multiple stages of skillful manual techniques. Each phase involved in the preparation is believed to have a cumulative impact on the efficacy of the Ksharasutra treatment. Hence, its manufacturing process is still predominantly manual, even in the current era. The manual preparation of Ksharasutra inherently leads to small-scale production and has restricted the availability of this effective treatment to a limited population. Secondly, due to manual preparation and use of different manufacturing techniques of Ksharasutra across the country, its effective production depends on the skill level of the persons involved in the process, and may lead to significant variability in quality. The key concerns regarding the quality standards such as uniform distribution of medicine along the thread, durability of the medicated thread, and hygienic preparation need to be addressed. At the same time, large-scale manufacturing of Ksharasutra should be planned for broad dissemination of this cost-effective treatment. The Central Council for Research in Ayurvedic Sciences (CCRAS), Ministry of Ayush, Govt. of India, in collaboration with the Indian Institute of Technology, New Delhi, has developed a prototype of an automated machine to manufacture the Ksharasutra. This clinical study will compare the effect of Ksharasutra prepared through an automated machine and manual process in the treatment of fistula-in-ano.

Objectives

The objectives of the study are to evaluate the clinical efficacy of Ksharasutra (prepared through two different techniques: automated machine and manually) in managing fistula-in-ano, to achieve complete cut-through of the fistula tract with simultaneous healing, to achieve change in the health-related quality of life, and to determine the safety of the Ksharasutra therapy in the treatment of fistula-in-ano.


  Materials and Methods Top


Study design and setting

This study is a double-blind, randomized controlled parallel-group trial. The study is being carried out at the Central Ayurveda Research Institute (CARI), New Delhi, India under the CCRAS, Ministry of Ayush, Government of India.

Study participants

Inclusion criteria

Patients of either sex aged 18–60 years diagnosed with fistula-in-ano complaining of perianal discharge, pain, tenderness, itching, and induration/swelling will be included in the study.

Exclusion criteria

Patients with high-level anal fistula, fistula connected with other organs (urethra or vagina), suffering from or having a history of tuberculosis, Crohn’s disease, ulcerative colitis, having evidence of HIV infection, uncontrolled diabetes mellitus, malignancy, bleeding diathesis, any other clinical condition which the investigator thinks may jeopardize the study, and those who have completed participation in any other clinical trial during the past 6 months will not be considered for the study.

Study intervention

Fistula-in-ano patients eligible for the study will be managed with Ksharasutra manufactured through an automated machine and manually prepared Ksharasutra in the intervention group and control group, respectively. The study participants of both the groups will be instructed to attend the follow-ups weekly for the change of Ksharasutra till complete cut-through of the fistula tract is achieved. All the study participants will be followed up for another 4 weeks after the healing of the fistula. The Ksharasutra procedure will be done by the principal investigator who is specialized in Ayurveda para-surgical techniques including Ksharasutra. Jatyadi Taila will be provided to the enrolled participants of both the study groups for per rectal administration twice daily for wound healing along with Triphala Churna 6 g orally at bedtime with lukewarm water for regulating the bowel movements.

Both types of Ksharasutra are manufactured at the CARI, New Delhi as per the standards available in the Ayurvedic Pharmacopoeia of India. Ksharasutra is prepared with Snuhi Ksheera (latex of Euphorbia neriifolia L.), Haridra Churna (Curcuma longa L.), and Apamarga Kshara (Achyranthes aspera L.).

Procedure of Ksharasutra therapy[

4]


Patients will be put in lithotomy position to locate the site of external opening of the fistula-in-ano. Proctoscopy will be performed to identify the internal opening of the fistula tract. A long metallic probe with an eye will be introduced through the external opening of the fistula tract. An attempt will be made to pass the tip of the malleable probe through the internal opening of the fistula tract. The eye of the metallic probe will be threaded with Ksharasutra. The entire fistula tract will be threaded with Ksharasutra, when the probe will be gently withdrawn from the tract. Then, the two ends of the Ksharasutra will be tied using two knots outside the anal canal. The change of Ksharasutra will be done every week until the complete cut-through of the fistula tract.

Outcome measures

The primary outcome is the change in quality of life assessed through a 36-Item Short Form (SF-36) Health Survey Questionnaire. The secondary outcome measures will be the unit cutting time (UCT) of the fistula tract and proportion of participants having complete healing with the Ksharasutra prepared through automated machine and manual process.

The UCT is the time taken (in days) to cut 1 cm of the fistula tract with simultaneous healing and is calculated by the following formula:

Proctoscopy and MRI fistulogram will be performed at the time of screening and after complete cut-through of the fistula tract. Further, the culture test of the first changed and last changed Ksharasutra will be done to assess the efficacy of Ksharasutra in preventing the secondary infections.

The schedule of enrolment, intervention, assessments, and follow-up visits for the study participants is given in [Table 1].
Table 1: Study schedule

Click here to view


Safety outcomes

The safety of the trial intervention will be assessed by recording the incidence of ADR/AE on every scheduled follow-up visit in the structured format. All adverse events during the study were monitored as per Good Clinical Practice (GCP-ICH) guidelines.

Withdrawal criteria

If any participant developed serious adverse events (SAEs) or treatment-emergent adverse events during the study period, they will be withdrawn from the study. Such cases will be given appropriate incidental care or will be referred to a higher medical facility. The participants not adhering to the study protocol or unwilling to continue their participation will also be withdrawn from the study. The reasons for the withdrawal will be recorded in the participant’s case record form (CRF). The Sponsor and the Ethics Committee will be notified of the decision to withdraw a participant from the trial due to SAE within 2 working days, along with proper justification. An attempt will be made to collect the data from the withdrawn participants through intermittent follow-up or telephonic conversation, if the participant will be willing for the same.

Sample size

The sample size for the study is calculated based on the difference in mean UCT of the fistula tract between the two study groups. Based on the results of a previously published study,[5] it is assumed that mean UCT will be 8.80 days/cm in patients treated with automated machine-prepared Ksharasutra when compared with 8.10 days/cm in those treated with manually prepared Ksharasutra. With a standard deviation of 1.15 days/cm, 80% power, and 95% confidence interval, a sample size of 42 per group would be enrolled in the study. Adding an attrition rate of 20%, the sample size per group will be 50. Therefore, a total of 100 participants will be enrolled in the study.

Recruitment

After obtaining written informed consent, patients diagnosed with fistula-in-ano will be screened for eligibility to participate in the study. The participants will be enrolled from the outpatient department of the study site. Participants will be recruited in the study based on the defined inclusion and exclusion criteria, and their allocation in either of the study groups shall be based on the randomization schedule.

Randomization

The eligible patients of fistula-in-ano will be randomized into two parallel groups in the ratio of 1:1 as per a statistician-generated random number sequence using the SPSS software version 15.0.

Allocation concealment and blinding

The study will be a double-blind trial in which the investigators and participants will be blinded. The trial interventions will be packed in identical boxes as per the randomization sequence. The enrolment ID of the participants will be serially labeled on the boxes. Each box will contain either automated machine-prepared Ksharasutra or manually prepared Ksharasutra as per the randomization sequence. An independent pharmacist who will not be related to the study will pack the trial interventions to ensure proper allocation, concealment, and blinding. To maintain the legitimacy of the clinical trial, unblinding of the participant’s code will be done only in exceptional circumstances when knowledge of the treatment prescribed is essential for further management of the study participant.

Masking

The automated machine and manually prepared Ksharasutra will be identical in color, appearance, and packing. The labels on both the trial drugs will be the same.

Compliance

Compliance will be monitored by assessing the participant’s attendance for the subsequent changes of Ksharasutra on scheduled follow-up visits. The compliance of prescribed medications will be evaluated by counting the number of containers returned, the approximate quantity of medications consumed by the participant, and the compliance assessment form issued to the participant. The patient will be continued in the study if the compliance is more than or equal to 80%.

Concomitant and rescue medication

Participants registered under the trial will be instructed to consult the study investigators before taking other medications for any ailment. The investigators will record the medication(s) they may prescribe to alleviate the participant’s ailments. To alleviate any medical emergency, the use of any rescue medication will be permitted. However, the same will have to be documented appropriately in the relevant section of the CRF.

Data collection and documentation

The clinical data relevant to the study outcomes will be collected from the study participants on the scheduled follow-up visits. The data collected during the follow-up visits will be entered in the respective CRFs. The data will be subsequently recorded in an e-format for statistical analysis and record.

Statistical analysis

Categorical data will be presented as numbers (percentage) and will be compared using the χ2 test/Fisher’s exact test. Normally distributed data will be presented as mean (±SD) and 95% confidence interval, and non-normally distributed data will be presented as median and IQ range. The within-group analysis will be done using paired sample t-test for normal data, whereas Wilcoxon signed-rank test will be used to compare non-normal data. Comparisons between groups will be done using independent sample t-test or Mann–Whitney test for normal and non-normal data, respectively. A P < 0.05 was considered statistically significant. Both the intention-to-treat and per-protocol analysis of the study data will be done. Data analysis will be performed using the STATA version 16.1.

Monitoring

The study will be monitored by the concerned officers of the funding agency through regular site visits. The Biostatistical Unit of the funding agency will review the e-format of the CRFs every fortnight. If required, an interim analysis can be done when at least 25% of the participants have completed their trial period.

Trial audit

The investigators will ensure access to all the source documents, CRFs, and other study documents for the on-site audit or inspection by the regulatory authorities, IEC, or the funding agency.

Ethics and dissemination

The study protocol has been prepared in accordance with the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines (SPIRIT checklist as Supplementary file 1). The study is approved by the Institutional Ethics Committee of the CARI, New Delhi vide letter no. 1–12/2020-CARI/Tech/IEC dated January 23, 2021 and is registered prospectively at the Clinical Trial Registry of India (CTRI/2021/12/038414). Written informed consent will be obtained from the eligible patients of fistula-in-ano by the investigators before screening (Supplementary file 2 for patient information sheet and consent form). The study will be conducted in accordance with the ICMR National Ethical Guidelines for Biomedical and Health Research on Human Participants (2017). The study outcomes will be disseminated through research articles in peer-reviewed scientific journals and presentations at national conferences.

Deviation from the protocol

The investigators will not alter or deviate from the protocol without prior approval from the IEC and the funding agency. All substantial amendments affecting patients’ safety or study integrity will need prior approval from the IEC before implementation in the study.

Confidentiality

All the study-related data will be stored securely at the trial site with password-protected access systems. All the information related to the study participants will be stored in areas with limited access. All the records and documents that contain personal identifiers will be stored separately from the study records identified by a code number. The data of each of the study participants will be coded to maintain participant confidentiality.

Ancillary and post-trial care

No ancillary studies are proposed with this clinical study. The study participants will be given routine medical care if required, after the completion of the study period.


  Discussion Top


Several conventional techniques have been evaluated over the last few decades in the management of fistula-in-ano to prevent its recurrence and associated complications. The conventional surgical treatment is associated with a significant recurrence rate and a high risk of impaired anal continence.[4],[6] Various treatment modalities, including Ksharasutra therapy, are enumerated in Ayurveda to manage fistula-in-ano. Ksharasutra is a big revolution in the management of fistula-in-ano as this intervention is simple, cost-effective, associated with least post-operative care, minimal complications, and low recurrence rate.[4] Better cure rate and marginal recurrence with Ksharasutra management are also evident from the results of published research studies.[7],[8] The conventional Ksharasutra is prepared with Haridra (C. longa L.), Snuhi (E. neriifolia L.) latex, and Apamarga Kshara (A. aspera L.) coated over the surgical linen thread. As per the Ayurveda classical texts, Kshara Dravya possesses Chedana (excision), Bhedhana (incision and drainage), and Lekhana (anti-slough and chemical curetting) properties.[9] In addition, Haridra has proven anti-inflammatory, anti-microbial, and wound-healing properties. Ksharasutra physically and chemically curettes the fistula tract and sloughs out the epithelial lining due to direct contact with the tract. It leads to simultaneous cutting and healing of the fistula tract and effective wound drainage.[3],[4]

Jatyadi Taila and Triphala Churna will also be prescribed to the enrolled participants of both the study groups. The administration of Jatyadi Taila per rectum produces a soothing effect at the anal canal. As per Ayurveda classical texts, due to Shodhana (cleansing) and Ropana (healing) properties, it is suggested for the management of Bhagandara and Dushta Vrana (infected wound).[10] The wound-healing action of Jatyadi Taila is also proven in published research studies.[11]Triphala Churna facilitates easy bowel evacuation due to its Anulomana (laxative) action.

Trial registration

Clinical Trial Registry of India (CTRI/2021/12/038414).

Trial status

Participants recruitment for the study started at the Central Ayurveda Research Institute, New Delhi, India.

Protocol number

CCRAS-IMR-FIA-01, version: 2.0 dated 05.03.2021.

Financial support and sponsorship

The CCRAS, Ministry of Ayush, Government of India is funding the study. The funding agency also provided technical support in study design and development of the study protocol.

Access to data

The funding agency, i.e., CCRAS, will have access to the final study data.

Authors’ contributions

BY and HKP conceived the study and initiated the study design. AKR finalized the study protocol and drafted the manuscript. The protocol was finalized with inputs from BC and NS. RS and RKR provided the statistical inputs. All authors contributed to the refinement of the study protocol and approved the final draft of the manuscript.

Conflicts of interest

The authors declare that they have no known competing interests.

Acknowledgments

The authors are thankful to Prof. Rabinarayan Acharya, Director-General, CCRAS, Ministry of Ayush, Government of India for his valuable guidance and administrative support and to Prof. D.T. Sahni, Ex-Professor, Design Division, Indian Institute of Technology, New Delhi for his contribution in developing the prototype of automated machine to manufacture Ksharasutra.


  Appendix A Top


Supplementary file 1: SPIRIT checklist.

Supplementary file 2: Consort form and patient information sheet.



Appendix A

Supplementary file 1: SPIRIT Checklist

SPIRIT 2013 Checklist: Recommended items to address in a clinical trial protocol and related documents*


Click here to view


Supplementary file 2: Consent form and patient information sheet

Patient information sheet

You are being invited to take part in a research study on automated machine and manually prepared Ksharasutra to treat the patients of fistula-in-ano. Before you decide it is important for you to understand why the research is being done and what it will involve. Please take time to read the following information carefully and discuss it with friends and relatives, if you wish to ask us if there is anything that is not clear or if you would like more information. Take time to decide whether or not you wish to take part.

  • 1. What is the purpose of the study?


This is a research study being conducted under the Intra Mural Clinical Research Program of Central Council for Research in Ayurvedic Sciences (CCRAS), Ministry of Ayush, Government of India, involving application of automated machine-prepared Ksharasutra in cases of fistula-in-ano with a view to scientifically document the clinical efficacy and safety of the said Ayurvedic treatment that have been in use since years for the management of fistula-in-ano (Bhagandara).

  • 2. Who can take part in the study?


Any individual aged 18–60 years and diagnosed case of fistula-in-ano will be eligible to participate. The study investigators will decide your eligibility to participate in the study based on an initial assessment and laboratory investigations.

  • 3. Do I have to take part?


It is up to you to decide whether or not to take part. If you do decide to take part you will be given this information sheet to keep and be asked to sign a consent form later. If you agree to take part you are still free to withdraw at any time and without giving any reason. This will not affect the standard of care you receive.

  • 4. What will happen to me if I take part?


If you agree to take part in this study you will be advised for Ayurvedic treatment, i.e., Ksharasutra which will be changed every week till the cut through of the fistula tract. You have to come every week for clinical examination as well as for changing of the thread. You have to undergo general physical examination and laboratory investigations from time to time for the assessment of the effect of the treatment. Investigations will include blood tests and radiological tests. In the first visit, i.e., on baseline (Day 1) you may have to devote approximately 2 h to facilitate your investigator in recording your medical history in detail. Thereafter, in the subsequent visits, it may take nearly 15–20 min to make the assessment.

  • 5. What do I have to do?


You have to adhere to the instructions given to you by your investigator regarding taking the medicines as advised and reporting for follow-up on the prescribed day.

  • 6. What is the drug or procedure that is being tested?


The participants enrolled in the clinical trial will be advised for Ksharasutra therapy. The Ksharasutra used for the therapy will be either automated machine-prepared Ksharasutra or manually prepared Ksharasutra. The type of Ksharasutra will be assigned randomly to the study participants.

  • 7. What are the alternatives for diagnosis or treatment?


Conventional surgery (fistulotomy or fistulectomy) is the alternative for the Ayurvedic treatment provided in this study.

  • 8. What are the expected side effects/risks of the treatment?


Ksharasutra therapy being prescribed to you have been safely advised since ancient times, yet individual specific side effects may appear at any time during the course of the clinical trial, which you are to report immediately to the study investigators.

  • 9. What are the possible benefits of taking part?


It is not assured that you will definitely get cured of your ailment after completing the Ksharasutra therapy but your participation will help us in generating sufficient data to validate the efficacy and safety of Ksharasutra therapy in the patients of Bhagandara.

  • 10. What if new information becomes available?


If, during the course of the clinical trial, any new information becomes available about the Ksharasutra therapy being studied, you will be informed about that by your investigator after which you are free to decide whether you want to continue in the study or not. If you decide to withdraw, this will not adversely affect your routine care in the hospital. If you decide to continue in the study, you will be asked to sign a fresh consent form. On the other hand, upon receiving new information, your investigator might consider it to be in your best interests to withdraw you from the study. Your investigator will explain the reasons for dropping you from the study and arrange for your routine care to continue.

  • 11. What happens when the research study stops?


You will be given appropriate advice for future line of treatment.

  • 12. What if something goes wrong?


Compensation for any adverse effect caused by taking part in this study would be taken care by appropriate treatment or referrals.

  • 13. Will my taking part in this study be kept confidential?


Yes, all your information will be kept confidential but any of your medical records may be inspected by the sponsor. They may also be looked at by the members of Institutional Ethics Committee and by Regulatory Authorities/Court to check that the study is being carried out correctly. Your name, however, will not be made public, and any sensitive matter regarding your state of health will be kept confidential.

  • 14. What will happen to the results of the research study?


The results of the clinical trial will be published in scientific journals so that other doctors and researchers can be benefited from the results. You can ask your investigator for a copy of the publication. If published, your identity and personal details will be kept strictly confidential. No named information about you will be published in any of the trial reports.

  • 15. Who is organizing and funding the research?


The Central Council for Research in Ayurvedic Sciences (CCRAS), Ministry of Ayush, Government of India is providing funds for the study and also coordinating and monitoring the study.

  • 16. Contact for further information


If desirous of any relevant information at any stage of the clinical trial, you may feel free to ask your investigator for that information. You would be given a copy of the information sheet and a copy of signed consent form.

Contact details of the investigators

Consent Form

(to be signed on the day of screening)

Title of the study: Randomized double-blind trial for clinical evaluation of Ksharasutra prepared manually and by automated machine in fistula-in-ano (Bhagandara)

  • Participant Enrollment ID: —————


  • Name of the Participant: ——————


  • I confirm that I have read the information sheet/the study has been explained to me adequately and I have understood the information regarding the study and had the opportunity to ask questions and all my questions have been answered satisfactorily.


  • I understand that my participation is voluntary and that I am free to withdraw at any time, without giving a reason, and without my medical care or legal rights being affected.


  • I understand that my doctor will provide information about my progress, in confidence, to the related officers of the sponsor. I understand that the information held by the investigators and researchers and records maintained by the sponsor might be used to follow-up my health status.


  • I understand that the information will be used for medical research only and that I will not be identified in any way in the analysis and reporting of the results. I understand that sections of any of my medical notes may be looked at by the sponsors or responsible individuals from the members of the IEC, Regulatory authorities or Court, if necessary. I give permission for these individuals to have access to my records.


  • I understand what is involved in this trial and agree to take part in the clinical trial for a period required to achieve complete cut-through of the fistula tract and follow-up of 4 weeks.


  • I have received a copy of the Participant Information Sheet and signed informed consent form.


  • Name of the Participant Signature/Thumb Impression Date

    Name of the Investigator Signature Date



     
      References Top

    1.
    Shastri A, editor. Sushruta Samhita of Sushruta, Sutra Sthana. Reprint edition. Chapter 33, Verse 4. Varanasi: Chaukhambha Sanskrit Sansthan; 2009. p. 163.  Back to cited text no. 1
        
    2.
    Limura E, Giordano P Modern management of anal fistula. World J Gastroenterol 2015;21:12-20.  Back to cited text no. 2
        
    3.
    Shukla NK, Narang R, Nair NG, Radhakrishna S, Satyavati GV Multicentric randomized controlled clinical trial of Ksharasutra (Ayurvedic medicated thread) in the management of fistula in ano. Indian J Med Res 1991;94:177‑85.  Back to cited text no. 3
        
    4.
    Dutta G, Bain J, Ray AK, Dey S, Das N, Das B Comparing Ksharasutra (ayurvedic seton) and open fistulotomy in the management of fistula-in-ano. J Nat Sci Biol Med 2015;6: 406-10.  Back to cited text no. 4
        
    5.
    Meena RK, Dudhamal T, Gupta SK, Mahanta V Comparative clinical study of Guggulu-based Ksharasutra in Bhagandara (fistula-in-ano) with or without partial fistulectomy. Ayu 2018;39:2-8.  Back to cited text no. 5
        
    6.
    Sherkhane R, Meena P, Hanifa N, Mahanta VD, Gupta SK IFTAK technique: An advanced Ksharasutra technique for management of fistula in ano. J Ayur Integr Med 2021;12:161-4.  Back to cited text no. 6
        
    7.
    Panigrahi HK, Rani R, Padhi MM, Lavekar GS Clinical evaluation of Ksharasutra therapy in the management of Bhagandara (fistula-in-ano)—A prospective study. Anc Sci Life 2009;28:29-35.  Back to cited text no. 7
        
    8.
    Pankaj S, Manoranjan S Efficacy of Ksharsutra (medicated seton) therapy in the management of fistula-in-ano. World J Colorectal Surg 2010;2:1-10.  Back to cited text no. 8
        
    9.
    Shastri A, editor. Sushruta, Sushruta Samhita, Sootra Sthana, Ksharapaka Vidhi Adhyaya, 11/3. Reprint Edition. Varanasi: Chaukhambha Sanskrita Sanshtan; 2009. p. 45.  Back to cited text no. 9
        
    10.
    Mishra SN, editor. Govind Das Sen, Bhaisajya Ratnavali, Mukharogadikar, 61/139‑142. 2nd ed. Varanasi: Chaukhambha Surbharati Prakashan; 2011. p. 965.  Back to cited text no. 10
        
    11.
    Shailajan S, Menon S, Pednekar S, Singh A Wound healing efficacy of Jatyadi Taila: In vivo evaluation in rat using excision wound model. J Ethnopharmacol 2011;138:99-104.  Back to cited text no. 11
        



     
     
        Tables

      [Table 1], [Table 2]



     

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